Comparative, Prospective, Randomized Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Number of Patients With Less Than Two Lymph Nodes Detected
Study Overview
Brief Summary
The sentinel node has a fundamental role in the management of early breast cancer.
Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. In many centers, this technique is not available. The use of blue is easier to implement technique. However, allergic reactions and prolonged breast tattoo led many teams to stop the practice.
So in common practice, many center use a single method. However, with a single detection, the risk of false negatives and the identification failure rate increased to a significant extent and the number of sentinel lymph node detected and removed is not enough.
Under these conditions, find another method of detection seems crucial. According to the literature, the fluorescence method (ICG) is a technique that seems safe and reliable.
The investigators therefore propose a prospective, randomized study to investigate the interest of fluorescence associated with the isotopic method.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Histologically proved infiltrating breast cancer (ductal, lobular carcinoma...) or a carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy...)
- •Unifocal or multifocal but in same quarter
- •Size < 5cm clinically palpable or not
- •Clinically or ultrasound axillary N0
- •Isotopic sentinel node detection
- •Adult patient
- •Signed informed consent by patient or legally responsable authority
- •Patient registered to a social security system
- •No surgical contra-indication
Exclusion Criteria
- •Mammary carcinoma recurrence
- •Previous same side mammary reduction
- •Previous lumpectomy
- •Contra-indication to surgery
- •Pregnant or breast feeding patient
- •Denial of participation
Arms & Interventions
double detection Indocyanine + isotope
intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery
Intervention: indocyanine green (Drug)
double detection Indocyanine + isotope
intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery
Intervention: isotope (Drug)
isotope detection alone
intradermal injection of 20 MBq of technetium 99 before breast surgery
Intervention: isotope (Drug)
Outcomes
Primary Outcomes
Number of Patients With Less Than Two Lymph Nodes Detected
Time Frame: peroperative
Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone
Secondary Outcomes
- Number of Lymph Nodes ICG Positive and Tc Positive(Peroperative)
- Comparison Between Groups of the Time of the Surgery(Peroperative)
- Comparison Between Groups of Time Surgery Node(Peroperative)
- Number of Patients With ICG Allergy(Month 2)
- Number of Lymph Nodes ICG Positive and Tc Negative(Peroperative)
- Comparison Between Groups of Anesthesia Time(Peroperative)
- Number of Lymph Nodes ICG Negative and Tc Positive(Peroperative)
- Time From Injection of One Dose ICG Injection to Incision Time(Peroperative)